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Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

Primary Purpose

Cardiac Arrhythmia

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

MNC-01

Placebo

About this trial

This is an interventional treatment trial for Cardiac Arrhythmia focused on measuring heart rhythm disturbances and symptoms, dietary supplement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

PVB in the long-term ECG recording (registration at least 18 hours): at least 500 PVB/24 h or Supraventricular tachycardia (≥10 episodes/24h, outside sporting activity) or SVPB with vegetative symptoms (increased sweating, inner unrest, shaky hands, red dermographism) and no cardial pretreatment

Exclusion Criteria:

Left ventricular ejection fraction [EF] ≤ 40 %
Therapy with spironolactone > 50 mg/d
Therapy with torasemide > 20 mg/d
Supplementation or therapy with dietary supplements or drugs which contain vitamins and minerals (above all potassium and magnesium)
Creatinine in the serum [i. S.]:≥ 1,4 mg/dl (men), ≥ 1,2 mg/dl (women)
Potassium i. S. ≤ 3,4 mmol/l and > 5,4 mmol/l
Magnesium i. S. ≤ 0,7 mmol/l and > 1,0 mmol/l
Acute and chronic diarrhea
Hyperthyroidism anamnestic or due to the current TSH (thyroid stimulating hormone)-value
Pacemaker

Sites / Locations

Elke Parsi assoc. Prof. MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MNC-01

Placebo

Arm Description

potassium, magnesium, and vitamins (MNC-01)

cellulose, microcrystalline [NF], HPMC E15,

Outcomes

Primary Outcome Measures

Evaluation of the changes in the perception of six symptoms

at baseline, at follow-up visit 4 (at the end of week three) and at follow-up visit 5 (at the end of study) by visual analogue scale [VAS]: complete summary to a total score value in comparison to baseline

Secondary Outcome Measures

symptom awareness and responder rate

the responder rates of the changes, measured by the amount of patients with a reduction of the total score value at follow-up visit 5 (at the end of study) in comparison to baseline of at least 20%

symptom awareness and changes during the study

evaluation of the changes in the awareness of six symptoms, namely: irregular heartbeat, palpitations, heart stumbling, sweating, dyspnea, and anxiety or panic attacks at baseline, at follow-up visit 4 (at the end of week three) and at the end of week six by VAS and summary to a total score value

absolute reduction in premature ventricular beat (PVB)

the absolute reduction of the PVB in 24 hours at follow-up visit 4 (at the end of week three) and follow-up visit 5 (at the end of study) in comparison to baseline

relative reduction of the premature ventricular beat (PVB)

the relative reduction of the PVB in 24 hours at follow-up visit 4 (at the end of week three) and follow-up visit 5 (at the end of study) in comparison to baseline

responder rate of the premature ventricular beat (PVB)

the responder rate measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study

absolute reduction of supraventricular premature beats (SVPB)

the absolute reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms

relative reduction of supraventricular premature beats (SVPB)

the relative reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms

responder rate

the responder rate, measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study

Full Information

NCT ID

NCT02652338

First Posted

December 16, 2015

Last Updated

January 7, 2016

Sponsor

Trommsdorff GmbH & Co. KG

Collaborators

Bonn Education Association for Dietetics r.A., Cologne, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02652338

Brief Title

Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

Official Title

Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Trommsdorff GmbH & Co. KG

Collaborators

Bonn Education Association for Dietetics r.A., Cologne, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main aim of this study, which was carried out in two parallel groups, is testing the efficacy of a specific micronutrients combination in adults with heart rhythm disturbances and accompanying symptoms. It is therefore the investigators hypothesis that daily oral administration of the specific micronutrients combination will lead to a decrease of symptoms awareness and to a reduction of heart rhythm disturbances in adults with or without structural heart disease. The principal endpoints will be a decrease in the total score of symptoms awareness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrhythmia

Keywords

heart rhythm disturbances and symptoms, dietary supplement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MNC-01

Arm Type

Active Comparator

Arm Description

potassium, magnesium, and vitamins (MNC-01)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

cellulose, microcrystalline [NF], HPMC E15,

Intervention Type

Dietary Supplement

Intervention Name(s)

MNC-01

Intervention Description

twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

Primary Outcome Measure Information:

Title

Evaluation of the changes in the perception of six symptoms

Description

Time Frame

end week 3 and week 6

Secondary Outcome Measure Information:

Title

symptom awareness and responder rate

Description

the responder rates of the changes, measured by the amount of patients with a reduction of the total score value at follow-up visit 5 (at the end of study) in comparison to baseline of at least 20%

Time Frame

end week 6

Title

symptom awareness and changes during the study

Description

Time Frame

end week 3 and week 6

Title

absolute reduction in premature ventricular beat (PVB)

Description

the absolute reduction of the PVB in 24 hours at follow-up visit 4 (at the end of week three) and follow-up visit 5 (at the end of study) in comparison to baseline

Time Frame

end week 3 and 6 week

Title

relative reduction of the premature ventricular beat (PVB)

Description

the relative reduction of the PVB in 24 hours at follow-up visit 4 (at the end of week three) and follow-up visit 5 (at the end of study) in comparison to baseline

Time Frame

end week 3 and week 6

Title

responder rate of the premature ventricular beat (PVB)

Description

the responder rate measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study

Time Frame

end week 3 and week 6

Title

absolute reduction of supraventricular premature beats (SVPB)

Description

the absolute reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms

Time Frame

end week 3 and week 6

Title

relative reduction of supraventricular premature beats (SVPB)

Description

the relative reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms

Time Frame

end week 3 and week 6

Title

responder rate

Description

the responder rate, measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study

Time Frame

end week 3 and week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: PVB in the long-term ECG recording (registration at least 18 hours): at least 500 PVB/24 h or Supraventricular tachycardia (≥10 episodes/24h, outside sporting activity) or SVPB with vegetative symptoms (increased sweating, inner unrest, shaky hands, red dermographism) and no cardial pretreatment Exclusion Criteria: Left ventricular ejection fraction [EF] ≤ 40 % Therapy with spironolactone > 50 mg/d Therapy with torasemide > 20 mg/d Supplementation or therapy with dietary supplements or drugs which contain vitamins and minerals (above all potassium and magnesium) Creatinine in the serum [i. S.]:≥ 1,4 mg/dl (men), ≥ 1,2 mg/dl (women) Potassium i. S. ≤ 3,4 mmol/l and > 5,4 mmol/l Magnesium i. S. ≤ 0,7 mmol/l and > 1,0 mmol/l Acute and chronic diarrhea Hyperthyroidism anamnestic or due to the current TSH (thyroid stimulating hormone)-value Pacemaker

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Metzner, Prof. MD

Organizational Affiliation

Bonn Education Association for Dietetics r. A.

Official's Role

Study Chair

Facility Information:

Facility Name

Elke Parsi assoc. Prof. MD

City

Berlin

ZIP/Postal Code

13053

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

30509185

Citation

Parsi E, Bitterlich N, Winkelmann A, Rosler D, Metzner C. Dietary intervention with a specific micronutrient combination for the treatment of patients with cardiac arrhythmias: the impact on insulin resistance and left ventricular function. BMC Cardiovasc Disord. 2018 Dec 3;18(1):220. doi: 10.1186/s12872-018-0954-6.

Results Reference

derived

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Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

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